Phase I Clinical Trials Investigating the Potential Efficacy of Axitinib in Patients With a BRCA 1/2 Mutations

Phase 1

Completed

• Conditions: Breast Neoplasms; Breast Cancer; HER-2 Protein Overexpression; Ovarian Cancer; BRCA Mutation; HER2-positive Breast Cancer; HER2-negative Breast Cancer; Ovarian Neoplasms
• Interventions: Drug: Axitinib

• Registration Number: NCT05904730
• Lead Sponsor: Lynkcell Europe

Brief Summary

This Clinical Trial is investigating the potential efficacy of axitinib after genetic testing in BRCA 1/2 Mutation patients, regardless of HER2 expression, who have progressed after at least one line of standard treatment or for whom there is no consensus treatment approach.

The use of Axitinib may help physicians plan for more effective patient care in combination with existing treatment protocols.

Detailed Description

This Clinical Trial is investigating the potential efficacy of axitinib after genetic testing in BRCA 1/2 Mutation patients, regardless of HER2 expression, who have progressed after at least one line of standard treatment or for whom there is no consensus treatment approach.

The use of Axitinib may help physicians plan for more effective patient care in combination with existing treatment protocols.

The addition of Axitinib to existing treatment protocols and to fractionated irradiation without functional normalization of the tumor vasculature can significantly improve response to therapy, contributing to the breakdown of the metabolic symbiosis of adaptive drug resistance.

Study Timeline

• Study First Submitted: 2023-06-06
• Study First Submitted QC: 2023-06-06
• Study First Posted: 2023-06-15
• Study Start: 2023-07-11
• Primary Completion: 2024-11-09
• Status Verified: 2024-12
• Study Completion: 2024-12-26
• Last Update Submitted: 2024-12-26
• Last Update Posted: 2024-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• histologically and immunohistochemically confirmed status of the tumor process
• мale or female, age ≥ 18 years
• Karnofsky performance status ≥ 60
• signed informed consent and willingness/ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures

Exclusion Criteria

• Grade 3 bleeding NCI CTCAE prior to study enrollment
• cardiac arrhythmias ≥2 according to NCI CTCAE with a corrected QT interval (QTcF) on the screening ECG >480 ms.
• pregnancy or breastfeeding. All female subjects of reproductive potential must have a negative pregnancy test (serum) prior to enrollment. Male subjects must be surgically sterile or must consent to the use of effective contraception during therapy.
• severe acute or chronic psychiatric condition or disorder with risk associated with participation in the study
• congestive heart failure (CHF) class III or higher according to the New York Heart Association (NYHA)
• subjects with arterial thrombotic events / venous thrombosis in the previous 12 months (axitinib has never been studied in this population)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Axitinib is 5 mg BID administered orally	Axitinib	The starting dose of Axitinib 5 mg BID administered orally with food.

Primary Outcome Measures

Name	Time	Method
Antitumor effect of axitinib (INLYTA) among patients with solid tumors with BRCA 1/2 mutations independent of HER2 expression, with progression after previous treatment, including radiotherapy	up to 90 days	Percent reduction of longest diameter of tumor and (or) metastases in millimeters

Trial Locations

Locations (1)

Trials TEAM; 🇺🇦 Kyiv, Ukraine